Download Attended Polysomnography for Evaluation of Sleep Disorders

UnitedHealthcare® Commercial
Medical Policy
ATTENDED POLYSOMNOGRAPHY FOR EVALUATION OF
SLEEP DISORDERS
Policy Number: 2017T0334X
Table of Contents
Page
INSTRUCTIONS FOR USE .......................................... 1
BENEFIT CONSIDERATIONS ...................................... 1
COVERAGE RATIONALE ............................................. 2
DEFINITIONS .......................................................... 3
APPLICABLE CODES ................................................. 6
DESCRIPTION OF SERVICES ...................................... 8
CLINICAL EVIDENCE ................................................. 9
U.S. FOOD AND DRUG ADMINISTRATION ................... 13
CENTERS FOR MEDICARE AND MEDICAID SERVICES ... 14
REFERENCES .......................................................... 14
POLICY HISTORY/REVISION INFORMATION ................ 16
Effective Date: April 1, 2017
Related Commercial Policies

Durable Medical Equipment, Orthotics, Ostomy
Supplies, Medical Supplies and Repairs/
Replacements

Obstructive Sleep Apnea Treatment
Community Plan Policy

Attended Polysomnography for Evaluation of Sleep
Disorders
Medicare Advantage Coverage Summary

Sleep Apnea: Diagnosis and Treatment
INSTRUCTIONS FOR USE
This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the
member specific benefit plan document must be referenced. The terms of the member specific benefit plan document
[e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ
greatly from the standard benefit plan upon which this Medical Policy is based. In the event of a conflict, the member
specific benefit plan document supersedes this Medical Policy. All reviewers must first identify member eligibility, any
federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Medical
Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its
sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational
purposes. It does not constitute medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in
administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent
professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or
medical advice.
BENEFIT CONSIDERATIONS
Before using this policy, please check the member specific benefit plan document and any federal or state mandates,
if applicable.
Indications for Coverage

Medical or surgical treatment of snoring is covered only if that treatment is determined to be part of a proven
treatment for documented obstructive sleep apnea (OSA). Refer to the applicable medical policy to determine if
the treatment proposed is proven for OSA.

Oral appliances for snoring with a diagnosis of OSA are addressed in the Coverage Determination Guideline titled
Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements.
Coverage Limitations and Exclusions

Medical treatment for primary snoring, without a diagnosis of OSA, that includes positive airway pressure (PAP)
equipment or oral appliances identified via a clinical review, is not a Covered Health Service.

Surgical treatments for primary snoring, without a diagnosis of OSA, are not a Covered Health Service. Examples
include, but are not limited to:
o Uvulopalatopharyngoplasty (UPPP)
o Laser-assisted uvulopalatoplasty (LAUP)
o Somnoplasty
o Submucosal radiofrequency tissue volume reduction
Attended Polysomnography for Evaluation of Sleep Disorders
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Essential Health Benefits for Individual and Small Group
For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured
non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten
categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small
group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to
provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be
removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is
made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit
plan document to determine benefit coverage.
COVERAGE RATIONALE
Home sleep apnea testing (HSAT), using a portable monitor, is medically necessary for evaluating adults
with suspected OSA.
Where HSAT is indicated, an auto-titrating continuous positive airway pressure (APAP) device is an option to
determine a fixed PAP pressure.
Attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting,
is medically necessary for evaluating individuals with suspected OSA when:

Results of previous HSAT are negative, indeterminate or technically inadequate to make a diagnosis of OSA; or

Patient is a child or adolescent (i.e., less than 18 years of age); or

Patient is known to have one or more of the following comorbid medical conditions that prohibits the use of a
HSAT:
o Significant chronic pulmonary disease as defined by a forced expiratory volume (FEV1) % predicted of <60
(Pellegrino et al., 2005)
o Progressive neuromuscular disease/neurodegenerative disorder (examples include, but are not limited to,
Parkinson’s disease, myotonic dystrophy, amyotrophic lateral sclerosis, multiple sclerosis with associated
pulmonary disease, history of stroke with persistent neurological sequelae)
o Moderate to severe heart failure (New York Heart Association class III or IV)
o Body mass index (BMI) >50 (DeMaria et al., 2007; Blackstone and Cortés, 2010)
o Obesity hypoventilation syndrome
o Documented ongoing epileptic seizures in the presence of symptoms of sleep disorder.
Also, see Repeat Testing section below.
When a diagnosis of OSA has been excluded or adequately treated, attended full-channel nocturnal
polysomnography, performed in a healthcare facility or laboratory setting, is medically necessary for
evaluating symptomatic individuals suspected of having one (1) or more of the following conditions:

Severe chronic periodic limb movement disorder (PLMD) (not leg movements associated with another disorder
such as sleep disordered breathing)

Restless legs syndrome (RLS)/Willis-Ekbom disease that has not responded to treatment

Parasomnia with documented disruptive, violent or potentially injurious sleep behavior suspicious of rapid eye
movement sleep behavior disorder (RBD)

Narcolepsy, once other causes of excessive sleepiness have been ruled out (also see MSLT section below)

Central sleep apnea
Attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting
is not medically necessary for diagnosing ANY of the following conditions:

Circadian rhythm disorders

Depression

Insomnia
There is insufficient published clinical evidence that evaluation of the above disorders with polysomnography (PSG) in
the absence of symptoms of sleep disorder leads to better health outcomes.
Actigraphy is not medically necessary for evaluating sleep-related breathing and circadian rhythm
disorders.
A review of the evidence does not establish the effectiveness of actigraphy as a stand-alone tool for the diagnosis of
OSA. In addition, definitive patient selection criteria for the use of actigraphy devices for the diagnosis of sleep apnea
have not been established. The evidence regarding the use of actigraphy for the evaluation of circadian rhythm
disorders is of low quality; therefore, the clinical utility cannot be established.
Attended Polysomnography for Evaluation of Sleep Disorders
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Daytime Sleep Studies
Multiple sleep latency testing (MSLT) is medically necessary for evaluating individuals with suspected
narcolepsy when other causes of excessive sleepiness have been excluded.
For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017,
Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).
Maintenance of wakefulness testing (MWT) is medically necessary for evaluating individuals whose
inability to remain awake constitutes a safety issue, or for assessing response to treatment in individuals
with narcolepsy or idiopathic hypersomnia.
For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017,
Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).
Multiple sleep latency testing (MSLT) and the maintenance of wakefulness test (MWT) are not medically
necessary for evaluating OSA, insomnia or circadian rhythm disorders.
Available published evidence is insufficient to demonstrate improved management of these conditions through the use
of MSLT. Published evidence is limited to poorly controlled studies.
An abbreviated daytime sleep study (PAP-Nap), to acclimate individuals to PAP and its delivery, is not
medically necessary.
Further results from large, prospective studies are needed to assess the clinical value of this test.
Attended PAP Titration
A split-night sleep study, performed in a healthcare facility or laboratory setting, is medically necessary
for diagnosis and PAP titration when an individual meets the above criteria for an attended sleep study.
When a split-night sleep study is inadequate or not feasible, a full-night study, performed in a healthcare
facility or laboratory setting, is medically necessary for PAP titration when an individual meets the above
criteria for an attended full-channel nocturnal polysomnography and has a confirmed diagnosis of OSA.
Also, see Repeat Testing section below.
Attended Repeat Testing
It may be necessary to perform repeat sleep studies. Where repeat testing is indicated, attended full-channel
nocturnal polysomnography, performed in a healthcare facility or laboratory setting, is medically necessary for
individuals who meet the above criteria for an attended sleep study. Repeat testing and repositioning/adjustments for
oral sleep appliances can be done in the home unless the patient meets criteria for an attended sleep study.
DEFINITIONS
Actigraphy: A measurement of physical activity, typically via a wrist-worn movement sensor, employed to estimate
sleep and wakefulness based on relative levels of physical inactivity and activity (ICSD-3, 2014).
Apnea: The cessation of airflow (≥90% decrease in airflow compared to baseline) lasting at least 10 seconds. Apneas
are classified as obstructive, mixed, or central based on the pattern of respiratory effort. An obstructive apnea is
associated with continued or increased inspiratory effort throughout the entire period of absent airflow. A central
apnea is associated with absent inspiratory effort throughout the entire period of absent airflow. Mixed apneas are
associated with absent inspiratory effort in the initial portion of the event, followed by resumption of inspiratory effort
in the second portion of the event (AASM Scoring Manual, 2016).
Apnea Hypopnea Index (AHI): The number of apneas plus the number of hypopneas, times 60, divided by total
sleep time (AASM Scoring Manual, 2016).
Central Disorders of Hypersomnolence: Sleep disorders in which the primary complaint is daytime sleepiness not
caused by disturbed nocturnal sleep or misaligned circadian rhythms (ICSD-3, 2014).
Central Sleep Apnea (CSA): A condition in which a person stops breathing during sleep because the brain
temporarily stops sending signals to the muscles that control breathing (Eckert et al., 2007).
Chronic Pulmonary Disease (CPD): A method of categorizing the severity of lung function impairment based on
forced expiratory volume (FEV1) % pred is provided in the below table. Severity of any spirometric abnormality based
on the forced expiratory volume in one second (FEV1).
Attended Polysomnography for Evaluation of Sleep Disorders
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Degree of Severity
Mild
FEV1 % pred
>70
Moderate
60-69
Moderately severe
50-59
Severe
35-49
Very Severe
<35
(Pellegrino et al., 2005)
Circadian Rhythm: An innate daily fluctuation of physiologic or behavior functions, including sleep-awake states,
generally tied to the 24-hour daily dark-light cycle. This rhythm sometimes occurs at a measurable different
periodicity (e.g., 23 or 25 hours when light-dark and other time cues are removed (AASM, 2001).
Circadian Rhythm Sleep-Wake Disorders: Sleep disorders caused by alterations of the circadian
time-keeping system, its entrainment mechanisms or a misalignment of the endogenous circadian rhythm and the
external environment (ICDS-3, 2014).
Epworth Sleepiness Scale (ESS): The ESS is an 8-item questionnaire which is used to determine the level of a
person’s daytime sleepiness. The ESS is based on the patient’s assessment of the likelihood of falling asleep in certain
situations commonly encountered in daily life. See the following website for further information:
http://epworthsleepinessscale.com/about-the-ess/. (Accessed August 16, 2016)
Excessive Sleepiness [Somnolence, Hypersomnia, Excessive Daytime Sleepiness (EDS)]: A subjective report
of difficulty in maintaining the alert awake state, usually accompanied by a rapid entrance into sleep when the person
is sedentary. Excessive sleepiness most commonly occurs during the daytime, but it may be present at night in a
person, such as a shift worker, who has the major sleep episode during the daytime (AASM, 2001).
Home Sleep Apnea Testing: The use of unattended diagnostic studies to assess for OSA without the determination
of sleep stage. The term specifies the condition being assessed (i.e., sleep apnea) by current technology without
implying that “sleep” quality, staging or time are determined. Not all such studies are performed at home; however,
that is where the vast majority of patients undergo these tests (AASM Style Guide, 2015). Also referred to as out-ofcenter sleep testing or portable monitoring.
Hypersomnia (Excessive Sleepiness): Excessively deep or prolonged major sleep period, which may be associated
with difficulty in awakening. The term is primarily used as a diagnostic term (e.g., idiopathic hypersomnia). The term
excessive sleepiness is preferred to describe the symptom (AASM, 2001).
Hypersomnolence: Excessive sleepiness during the normal wake period (ICSD-3, 2014).
Hypopnea: An abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in
airflow and with at least a 4% decrease in oxygen saturation as compared to baseline (AASM Scoring Manual, 2016).
Insomnia: A persistent difficulty with sleep initiation, duration, consolidation or quality that occurs despite adequate
opportunity and circumstances for sleep, and results in some form of daytime impairment (ICSD-3, 2014).
Maintenance of Wakefulness Test (MWT): A series of measurements of the interval from “lights out” to sleep
onset that are used in the assessment of an individual’s ability to remain awake. Subjects are instructed to try to
remain awake in a darkened room while in a semi reclined position. Long latencies to sleep are indicative of the
ability to remain awake. This test is most useful for assessing the effects of sleep disorders or of medication upon the
ability to remain awake (AASM, 2001).
Monitoring Time: Total recording time minus periods of artifact and time the patient was awake as determined by
actigraphy, body position sensor, respiratory pattern or patient diary. Monitoring time is used to calculate the
respiratory event index for home sleep apnea testing (AASM Scoring Manual, 2016).
Multiple Sleep Latency Test (MSLT): A series of measurements of the interval from “lights out” to sleep onset that
is used in the assessment of excessive sleepiness. Subjects are allowed a fixed number of opportunities (typically
four or five) to fall asleep during their customary awake period. Excessive sleepiness is characterized by short
latencies. Long latencies are helpful in distinguishing physical tiredness or fatigue from true sleepiness (AASM, 2001).
Attended Polysomnography for Evaluation of Sleep Disorders
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Medically Necessary: Health care services provided for the purpose of preventing, evaluating, diagnosing or treating
a sickness, injury, mental illness, substance use disorder, disease or its symptoms, that are all of the following as
determined by us or our designee, within our sole discretion.

In accordance with Generally Accepted Standards of Medical Practice

Clinically appropriate, in terms of type, frequency, extent, site and duration and considered effective for a sickness,
injury, mental illness, substance use disorder, disease or its symptoms

Not mainly for the convenience of the member or that of the doctor or other health care provider

Not more costly than an alternative drug, service(s) or supply that is at least as likely to produce equivalent
therapeutic or diagnostic results as to the diagnosis or treatment of a sickness, injury, disease or symptoms
Generally Accepted Standards of Medical Practice are standards that are based on credible scientific evidence
published in peer-reviewed medical literature generally recognized by the relevant medical community, relying
primarily on controlled clinical trials, or, if not available, observational studies from more than one institution that
suggest a causal relationship between the service or treatment and health outcomes.
If no credible scientific evidence is available, then standards based on physician specialty society recommendations or
professional standards of care may be considered. We reserve the right to consult expert opinion in determining
whether health care services are Medically Necessary. The decision to apply physician specialty society
recommendations, the choice of expert and the determination of when to use any such expert opinion, shall be within
our sole discretion (UnitedHealthcare 2011 Certificate of Coverage).
Narcolepsy: A condition in which a person experiences excessive daytime sleepiness and may fall asleep at
unexpected times, such as during work, school or driving. Narcolepsy type 1 is characterized by excessive daytime
sleepiness, cataplexy and/or low or absent cerebrospinal fluid hypocretin-1 levels (ICSD-3, 2014). Narcolepsy type 2
is characterized by excessive daytime sleepiness, without cataplexy, with unmeasured or normal cerebrospinal fluid
hypocretin-1 levels (ICSD-3, 2014).
2
Obesity Hypoventilation Syndrome (OHS): A breathing disorder characterized by obesity (BMI > 30 kg/m ) and
daytime hypercapnia (arterial PaCO2 > 45 mm Hg) that cannot be fully attributed to an underlying cardiopulmonary
or neurologic disease. The condition leads to low oxygen levels and too much carbon dioxide in the blood (ICSD-3,
2014).
Obstructive Sleep Apnea (OSA): A condition in which a person stops breathing during sleep due to a narrowed or
closed airway.
PAP-Nap: PAP-Nap is a daytime, abbreviated cardio-respiratory sleep study for patients who experience anxiety
about starting PAP therapy or are having problems tolerating PAP therapy. The test combines psychological and
physiological treatments into one procedure and includes mask and pressure desensitization, emotion-focused therapy
to overcome aversive emotional reactions, mental imagery to divert patient attention from mask or pressure
sensations and physiological exposure to PAP therapy during a 100-minute nap period (Krakow et al., 2008).
Parasomnia: Parasomnias are undesirable physical events or experiences that occur during entry into sleep, within
sleep or during arousal from sleep. They may occur during non-rapid eye movement sleep, rapid eye movement sleep
(REM) or during transitions to and from sleep. Parasomnias encompass abnormal sleep related complex movements,
behaviors, emotions, perceptions, dreams and autonomic nervous system activity. They are clinical disorders because
of the resulting injuries, sleep disruption, adverse health effects and untoward psychosocial effects (ICSD-3, 2014).
Also see RBD.
Periodic Limb Movements of Sleep (PLMS): Movements of the limbs during sleep occurring with a specified
frequency, duration and amplitude (AASM Scoring Manual, 2016).
Periodic Limb Movement Arousal Index (PLMAI): The number of PLMS associated with an arousal, times 60,
divided by total sleep time (AASM Scoring Manual, 2016).
Periodic Limb Movement Disorder (PLMD): A sleep disorder characterized by periodic episodes of repetitive,
highly stereotyped limb movements that occur during sleep, in conjunction with clinical sleep disturbance or fatigue
that cannot be accounted for by another primary sleep disorder or other etiology. PLMS occur most frequently in the
lower extremities. They typically involve extension of the big toe, often in combination with partial flexion of the ankle,
the knee and sometimes, the hip. Similar movements can occur in the upper limbs (ICSD-3, 2014).
Degree of Severity
Mild
Description
Associated with a PLMI of 5-24 per hour and results in mild insomnia or mild
sleepiness
Attended Polysomnography for Evaluation of Sleep Disorders
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Degree of Severity
Moderate
Severe
Type
Acute
Subacute
Chronic
Description
Associated with a PLMI of 25-49 per hour and results in moderate insomnia or
sleepiness
Associated with a PLMI of greater than 50 per hour or a PLMAI of greater than 25 per
hour and results in severe insomnia or sleepiness
Duration
1 month or less
Greater than 1 month but less than 6 months
6 months or longer
(Hening et al., 1999)
Periodic Limb Movement Index (PLMI): The number of PLMS, times 60, divided by total sleep time (AASM Scoring
Manual, 2016).
Polysomnogram: The continuous and simultaneous recording of multiple physiologic variables during sleep, i.e.,
electroencephalogram, electrooculogram, electromyogram (these are the three basic stage-scoring parameters),
electrocardiogram, respiratory air flow, respiratory movements, leg movements and other electrophysiologic variables
(AASM, 2001).
Positive Airway Pressure (PAP): A PAP device is an air pump (fan-driven or turbine system) that draws in external,
filtered air and delivers pressurized airflow to keep an individual’s airway open. PAP devices are divided into four basic
types depending on their pressure delivery system:

Continuous Positive Airway Pressure (CPAP): Delivers a steady, fixed flow of air pressure on inhalation

Bilevel Positive Airway Pressure (BPAP): Delivers a higher flow of air pressure on inhalation than exhalation

Autotitrating Positive Airway Pressure (APAP): Automatically changes the flow of air pressure (CPAP or BPAP)
based on an individual’s breathing patterns

Adaptive Servoventilation (ASV): Uses a servocontroller to automatically adjust the flow of air pressure by breathby-breath analysis to maintain a steady minute ventilation (Kushida et al., 2008).
Rapid Eye Movement Sleep Behavior Disorder (RBD): A parasomnia characterized by abnormal behaviors
emerging during REM sleep that may cause injury or sleep disruption (ICSD-3, 2014).
Respiratory Disturbance Index (RDI): The number of apneas plus the number of hypopneas plus the number of
respiratory effort-related arousals, times 60, divided by total sleep time (AASM Scoring Manual, 2016).
Respiratory Effort-Related Arousal (RERA): A sequence of breaths characterized by increasing respiratory effort,
inspiratory flattening in the nasal pressure or PAP device flow channel or an increase in end-tidal PCO2 (children)
leading to an arousal from sleep. Respiratory effort-related arousals do not meet criteria for hypopnea and have a
minimum duration of at least 10 seconds in adults or the duration of at least two breaths in children (AASM Scoring
Manual, 2016).
Respiratory Event Index (REI): Total number of respiratory events scored, times 60, divided by monitoring time.
The REI is used for home sleep apnea testing (AASM Scoring Manual, 2016).
Restless Legs Syndrome (RLS)/Willis-Ekbom Disease: RLS is a sensorimotor disorder characterized by a
complaint of a strong, irresistible urge to move the limbs. This urge to move is often, but not always, accompanied by
other uncomfortable sensations felt deep inside the limbs or by a feeling that is difficult or impossible to describe.
Although the legs are most prominently affected, these sensations may occur in the arms as well (ICSD-3, 2014).
APPLICABLE CODES
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all
inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or noncovered health service. Benefit coverage for health services is determined by the member specific benefit plan
document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply
any right to reimbursement or guarantee claim payment. Other Policies and Coverage Determination Guidelines may
apply.
Attended Polysomnography for Evaluation of Sleep Disorders
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CPT Code
0381T
Description
External heart rate and 3-axis accelerometer data recording up to 14 days to assess
changes in heart rate and to monitor motion analysis for the purposes of diagnosing
nocturnal epilepsy seizure events; includes report, scanning analysis with report,
review and interpretation by a physician or other qualified health care professional
0382T
External heart rate and 3-axis accelerometer data recording up to 14 days to assess
changes in heart rate and to monitor motion analysis for the purposes of diagnosing
nocturnal epilepsy seizure events; review and interpretation only
0383T
External heart rate and 3-axis accelerometer data recording from 15 to 30 days to
assess changes in heart rate and to monitor motion analysis for the purposes of
diagnosing nocturnal epilepsy seizure events; includes report, scanning analysis with
report, review and interpretation by a physician or other qualified health care
professional
0384T
External heart rate and 3-axis accelerometer data recording from 15 to 30 days to
assess changes in heart rate and to monitor motion analysis for the purposes of
diagnosing nocturnal epilepsy seizure events; review and interpretation only
0385T
External heart rate and 3-axis accelerometer data recording more than 30 days to
assess changes in heart rate and to monitor motion analysis for the purposes of
diagnosing nocturnal epilepsy seizure events; includes report, scanning analysis with
report, review and interpretation by a physician or other qualified health care
professional
0386T
External heart rate and 3-axis accelerometer data recording more than 30 days to
assess changes in heart rate and to monitor motion analysis for the purposes of
diagnosing nocturnal epilepsy seizure events; review and interpretation only
95782
Polysomnography; younger than 6 years, sleep staging with 4 or more additional
parameters of sleep, attended by a technologist
95783
Polysomnography; younger than 6 years, sleep staging with 4 or more additional
parameters of sleep, with initiation of continuous positive airway pressure therapy or
bi-level ventilation, attended by a technologist
95800
Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation,
respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time
95801
Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen
saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone)
95803
Actigraphy testing, recording, analysis, interpretation, and report (minimum of 72
hours to 14 consecutive days of recording).
95805
Multiple sleep latency or maintenance of wakefulness testing, recording, analysis and
interpretation of physiological measurements of sleep during multiple trials to assess
sleepiness
95806
Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation,
respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement)
95807
Sleep study, simultaneous recording of ventilation, respiratory effort, ECG or heart
rate, and oxygen saturation, attended by a technologist
95808
Polysomnography; sleep staging with 1-3 additional parameters of sleep, attended by
a technologist
95810
Polysomnography; sleep staging with 4 or more additional parameters of sleep,
attended by a technologist
95811
Polysomnography; sleep staging with 4 or more additional parameters of sleep, with
initiation of continuous positive airway pressure therapy or bilevel ventilation,
attended by technologist
CPT® is a registered trademark of the American Medical Association
HCPCS Code
G0398
G0399
Description
Home sleep study test (HST) with type II portable monitor, unattended; minimum of
7 channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort and oxygen
saturation
Home sleep test (HST) with type III portable monitor, unattended; minimum of 4
channels: 2 respiratory movement/airflow, 1 ECG/heart rate and 1 oxygen saturation
Attended Polysomnography for Evaluation of Sleep Disorders
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HCPCS Code
G0400
Description
Home sleep test (HST) with type IV portable monitor, unattended; minimum of 3
channels
DESCRIPTION OF SERVICES
Sleep disorders are conditions that affect an individual’s normal sleep patterns and can have an impact on quality of
life. One of the most common sleep disorders is obstructive sleep apnea (OSA), a condition in which a person stops
breathing during sleep due to a narrowed or closed airway. Symptoms of OSA include daytime sleepiness, loud
snoring and breathing interruptions or awakenings due to gasping or choking. If left untreated, OSA can lead to
serious health consequences such as hypertension, heart disease, stroke, insulin resistance and obesity. Other sleep
disorders include central sleep apnea, periodic limb movement disorder (PLMD), narcolepsy, restless legs syndrome,
parasomnias and insomnia.
The evaluation of sleep disorders can be done at home or in a specialized sleep center that can study sleep patterns
during the day or at night. Home sleep apnea testing (HSAT) is used to diagnose OSA and records breathing rate,
airflow, heart rate and blood oxygen levels during sleep. These studies are performed at home without a sleep
technician present (unattended). Polysomnography (PSG) records breathing, heart rate, blood oxygen levels, body
movements, brain activity and eye movements during sleep. PSG is performed in a laboratory setting with a sleep
technician present (attended) (American Thoracic Society, 2015).
Once a diagnosis of OSA is made, a PAP trial (titration) is performed to determine the optimal amount of pressure
needed to prevent the airway from narrowing or closing. An attended split-night study combines diagnostic
polysomnography and PAP titration into a single night (American Thoracic Society, 2015).
Sleep studies conducted during the day include the Multiple Sleep Latency Test (MSLT) and Maintenance of
Wakefulness Test (MWT). MSLT is performed to measure daytime sleepiness and is most often used to diagnose
narcolepsy. MWT is performed to measure how well a person can stay awake. In addition to diagnosing sleep
disorders, PSG may also be used to assess and adjust the treatment plan (American Thoracic Society, 2015).
Additional Information
According to the American Academy of Sleep Medicine (AASM) (Epstein et al., 2009), the diagnosis of OSA is
confirmed if the number of obstructive events (apneas, hypopneas + respiratory event related arousals) on PSG is
greater than 15 events/hour in the absence of associated symptoms or greater than 5/hour in a patient who reports
any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue;
insomnia; waking up breath holding, gasping or choking; or the bed partner describing loud snoring, breathing
interruptions, or both during the patient’s sleep.
The frequency of obstructive events is reported as an AHI or RDI. RDI has at times been used synonymously with AHI,
but at other times has included the total of apneas, hypopneas, and respiratory effort related arousals (RERAs) per
hour of sleep. When a portable monitor is used that does not measure sleep, the RDI refers to the number of apneas
plus hypopneas per hour of recording.
OSA severity is defined as:
 Mild for AHI or RDI ≥ 5 and < 15
 Moderate for AHI or RDI ≥ 15 and ≤ 30
 Severe for AHI or RDI > 30/hr
The AASM classifies sleep study devices (sometimes referred to as Type or Level) as follows (Collop et al., 2007):
 Type 1: Full attended PSG (≥ 7 channels) in a laboratory setting
 Type 2: Full unattended PSG (≥ 7 channels)
 Type 3: Limited channel devices (usually using 4–7 channels)
 Type 4: 1 or 2 channels usually using oximetry as 1 of the parameters
This classification system was introduced in 1994 and closely mirrored available Current Procedural Terminology (CPT)
codes. However, since that time, devices have been developed which do not fit well within that classification scheme.
In 2011, Collop et al. presented a new classification system for out-of-center (OOC) testing devices that details the
type of signals measured by these devices. This proposed system categorizes OOC devices based on measurements of
Sleep, Cardiovascular, Oximetry, Position, Effort, and Respiratory (SCOPER) parameters. Additional information can be
found at http://www.aasmnet.org/Resources/PracticeParameters/Outofcenter.pdf. (Accessed August 16, 2016)
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Multiple-Night Home Sleep Testing Versus One-Night Home Sleep Testing
Results of clinical studies demonstrate that night-to-night variability in home sleep testing is comparable to
laboratory-based PSG. The reported RDI variability is small and a single night testing can correctly diagnose
obstructive sleep apnea (OSA) in the majority of patients with a high pretest-probability of OSA. Reported data loss
for unattended portable monitoring ranges from 3%-33%. For a new device with an audible alarm only 2% of sleep
testing resulted in insufficient data. In instances where a technical failure occurs, a second night home sleep test may
be warranted. If home sleep testing in the high-risk patient is normal or technically inadequate the AASM recommends
in-laboratory PSG (Collop et al., 2007).
CLINICAL EVIDENCE
In 2011, AHRQ published a comparative effectiveness review on the diagnosis and treatment of OSA in adults (Balk et
al., 2011). The key questions focus on OSA screening and diagnosis, treatments, associations between AHI and
clinical outcomes and predictors of treatment compliance.
Findings:

The strength of evidence is moderate that Type III and Type IV monitors may have the ability to accurately
predict AHI suggestive of OSA with high positive likelihood ratios and low negative likelihood ratios for various AHI
cutoffs in PSG. Type III monitors perform better than Type IV monitors at AHI cutoffs of 5, 10, and 15 events/hr.
Large differences compared with in-laboratory PSG cannot be excluded for all portable monitors. The evidence is
insufficient to adequately compare specific monitors to each other.

The strength of evidence is low that the Berlin Questionnaire is able to prescreen patients with OSA with moderate
accuracy. There is insufficient evidence to evaluate other questionnaires or clinical prediction rules.

No study adequately addressed phased testing for OSA.

There was insufficient evidence on routine preoperative testing for OSA.

High strength of evidence indicates an AHI >30 events/hr is an independent predictor of death; lesser evidence
for other outcomes.

There is moderate evidence that CPAP is an effective treatment for OSA. There is also moderate evidence that
autotitrating and fixed CPAP have similar effects. There is insufficient evidence regarding comparisons of other
CPAP devices.

The strength of evidence is moderate that oral devices are effective treatment for OSA. There is moderate
evidence that CPAP is superior to oral devices.

There was insufficient trial evidence regarding the relative value of most other OSA interventions, including
surgery.

The strength of evidence is high and moderate, respectively, that AHI and ESS are independent predictors of CPAP
compliance.

There is low evidence that some treatments improve CPAP compliance.
The report concluded that portable monitors and questionnaires may be effective screening tools, but assessments
with clinical outcomes are necessary to prove their value over PSG. CPAP is highly effective in minimizing AHI and
improving sleepiness. Oral devices are also effective, although not as effective as CPAP. Other interventions, including
those to improve compliance, have not been adequately tested.
Flemons et al. (2003) did a comprehensive review of the published literature on portable monitors for PSG. The review
was co-sponsored by the AASM, the American College of Chest Physicians (ACCP) and the American Thoracic Society
(ATS). The authors concluded that the use of portable monitoring as an initial diagnostic tool for selected patients may
reduce costs because patients with positive results could go ahead with CPAP titration studies and patients with
negative results might not require additional testing.
In 2011, Collop et al. reported the results of a technology evaluation of sleep testing devices used in the out-of-center
(OOC) setting performed by an AASM task force. Only peer-reviewed English literature and devices measuring 2 or
more bioparameters were included in the analysis. Studies evaluating 20 different devices or models (e.g., ARES,
ApneaLink, Embletta, Novasom QSG/Bedbugg/Silent Night, SNAP, Stardust II, Watch-PAT) were reviewed. Devices
were judged on whether or not they can produce a positive likelihood ratio (LR+) of at least 5 and a sensitivity of at
least 0.825 at an in-lab AHI of at least 5. The authors concluded that:

The literature is currently inadequate to state with confidence that a thermistor alone without any effort sensor is
adequate to diagnose OSA;

If a thermal sensing device is used as the only measure of respiration, 2 effort belts are required as part of the
montage and piezoelectric belts are acceptable in this context;

Nasal pressure can be an adequate measurement of respiration with no effort measure with the caveat that this
may be device specific;

Nasal pressure may be used in combination with either 2 piezoelectric or respiratory inductance plethysmographic
(RIP) belts (but not 1 piezoelectric belt);
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

There is insufficient evidence to state that both nasal pressure and thermistor are required to adequately diagnose
OSA;
With respect to alternative devices for diagnosing OSA, the data indicate that
o Peripheral arterial tonometry (PAT) devices are adequate for the proposed use;
o The device based on cardiac signals shows promise, but more study is required as it has not been tested in
the home setting;
o For the device based on end-tidal CO2 (ETCO2), it appears to be adequate for a hospital population; and for
devices utilizing acoustic signals;
o The data are insufficient to determine whether the use of acoustic signals with other signals as a substitute for
airflow is adequate to diagnose OSA.
For details regarding specific devices see full text article at:
http://www.aasmnet.org/Resources/PracticeParameters/Outofcenter.pdf. (Accessed August 16, 2016)
Single-Night Versus Multiple-Night Home Sleep Testing
A single-night PSG is usually considered adequate to determine if OSA is present and the degree of the disorder.
Since the PSG is considered the reference standard, the reliability and technical accuracy of PSG is generally accepted
without question. However, PSG, even when accurately measured, recorded and analyzed, may misclassify patients
based upon night-to-night variability in measured parameters. For example, estimates of the sensitivity of one night
of PSG to detect an AHI > 5 in patients with OSA range between 75 to 88% (Kushida et al., 2005).
Levendowski et al. (2009) published the first study that investigated the variability of AHI obtained by PSG and by inhome portable recording in 37 untreated mild to moderate OSA patients at a four- to six-month interval. The in-home
studies were performed with Apnea Risk Evaluation System (ARES™) Unicorder. When comparing the test-retest AHI
and apnea index (AI), the in-home results were more highly correlated (r = 0.65 and 0.68) than the comparable PSG
results (r = 0.56 and 0.58). The in-home results provided approximately 50% less test-retest variability than the
comparable PSG AHI and AI values. Both the overall PSG AHI and AI showed a substantial bias toward increased
severity upon retest (8 and 6 events/hr respectively) while the in-home bias was essentially zero. The in-home
percentage of time supine showed a better correlation compared to PSG (r = 0.72 vs. 0.43). Patients biased toward
more time supine during the initial PSG. No trends in time supine for in-home studies were noted.
Night-to-night variability in home sleep testing was previously assessed in a number of clinical studies. Most of these
studies involved a small number of patients. Redline et al. (1991), Quan et al. (2002; erratum 2009) and Davidson et
al. (2003) found no evidence of a statistically significant difference in RDI between nights 1 and 2, suggesting that
there was no significant respiratory first-night effect.
Fietze et al. (2004) investigated the night-to-night variability and diagnostic accuracy of the oxygen desaturation
index (ODI) in 35 patients using the portable recording device MESAM-IV at home during 7 consecutive nights. The
authors found that although the reliability of the ODI was adequate, the probability of placing the patient in the wrong
severity category (ODI < or =15 or ODI >15) when only one single recording was taken is 14.4%. The authors
concluded that in most OSA patients, oxygen desaturation index variability is rather small, and screening could be
reliably based on single 1-night recordings.
The largest study by Stepnowsky et al. (2004) examined the nightly variability of AHI in a retrospective comparison of
3 sequential nights of testing performed in the home in 1091 patients who were referred for diagnostic testing of
sleep-disordered breathing (SDB). Based on night 1, approximately 90% of patients were classified consistently with
"AHI-high" (the highest AHI measured across the 3 nights) using an AHI threshold of 5. However, 10% were
misclassified on night 1 relative to the highest AHI level. The authors concluded that there is little, if any, significant
nightly change in SDB in the home environment.
The results of these clinical studies demonstrate, that night-to night variability in home sleep testing is comparable to
laboratory-based PSG and that a single night testing can correctly diagnose OSA in the majority of patients with a
high pretest-probability of OSA.
Home-Based Versus In-Laboratory Diagnostic and Therapeutic Pathway
Recent comparative effectiveness research studies have shown that clinical outcomes of patients with a high pretest
probability for obstructive sleep apnea who receive ambulatory management using portable-monitor testing have
similar functional outcomes and adherence to CPAP treatment, compared to patients managed with in-laboratory PSG
(Kuna, 2010).
Mulgrew et al. (2007) randomly assigned 68 high-risk patients identified by a diagnostic algorithm to PSG or
ambulatory titration by using a combination of auto-CPAP and overnight oximetry. After 3 months, there were no
differences in AHI on CPAP between the PSG and ambulatory groups, or in the ESS score, or quality of life. Adherence
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to CPAP therapy was better in the ambulatory group than in the PSG group. Results of another randomized controlled
multicenter non inferiority study by Antic et al. (2009) that compared nurse-led home diagnosis and CPAP therapy
with physician-led current best practice in OSA management in 195 patients complement and extend the findings of
Mulgrew et al. There were no differences between both groups in ESS score and CPAP adherence at 3 months. Withintrial costs were significantly less in the simplified home model. Cost-effectiveness of home APAP titration compared to
manual laboratory titration was also confirmed by McArdle et al. (2010). In this randomized controlled study involving
249 patients with moderate to severe OSA without serious co-morbidities, outcomes at one month indicated that
average nightly CPAP use, subjective sleepiness, quality of life, cognitive function and polysomnographic outcomes
were similar among the per-protocol groups.
Berry et al. (2008) compared a clinical pathway using portable monitoring (PM) for diagnosis and unattended APAP for
selecting an effective CPAP with another pathway using PSG for diagnosis and treatment of OSA in a randomized
parallel group study involving 106 patients with a high likelihood of having OSA. After 6 weeks of treatment 40
patients in the PM-APAP group and 39 in the PSG arm were using CPAP treatment. The mean nightly adherence,
decrease in ESS score, improvement in functional score and CPAP satisfaction did not differ between the groups.
In a randomized controlled study involving 102 patients with suspected OSA, Skomro et al. (2010) compared a homebased diagnostic and therapeutic strategy for OSA with in-laboratory PSG and CPAP titration (using mostly split-night
protocol). Subjects in the home monitoring arm underwent 1 night of level three testing (Embletta) followed by 1
week of auto-CPAP therapy (Auto-Set) and 3 weeks of fixed-pressure CPAP based on the 95% pressure derived from
the auto-CPAP device. After 4 weeks of CPAP therapy, there were no significant differences in daytime sleepiness
(ESS), sleep quality, quality of life, blood pressure and CPAP adherence.
In another randomized controlled non-inferiority study Kuna et al. (2011) compared functional outcome and treatment
adherence in veterans with suspected OSA who received ambulatory versus in-laboratory testing for OSA. Home
testing consisted of a type 3 portable monitor recording (Embletta) followed by at least three nights using an APAP
device (RemStar Auto). In-laboratory testing was performed as a split-night PSG if clinically indicated. Of the 296
subjects enrolled, 260 (88%) were diagnosed with OSA, and 213 (75%) were initiated on CPAP. At 3 months of CPAP
treatment the functional outcome score improved 1.74 ± 2.81 in the home group and 1.85 ± 2.46 in the in-laboratory
group. CPAP adherence was 3.5 ± 2.5 hours/day in the home group and 2.9 ± 2.3 hours/day in the in-laboratory
group (P = 0.08).
Lettieri et al. (2011) conducted an observational cohort study including 210 patients with OSA that were grouped into
one of three pathways based on the type and location of their diagnostic and titration. Group 1 underwent unattended,
type III home diagnostic (Stardust II) and unattended home APAP titrations (Respironics System One); group 2
underwent in-laboratory, type I diagnostic and CPAP titration studies; group 3 underwent type I diagnostic and APAP
titration studies. Group 1 was primarily managed and educated in a primary care clinic, whereas groups 2 and 3
received extensive education in an academic sleep medicine center. The authors found that type of study and location
of care did not affect PAP adherence. Patients in all three pathways demonstrated equivalent use of PAP despite
differences in polysomnographic procedures, clinical education and follow-up.
A single-blind randomized controlled trial with 200 CPAP-naive patients found home-based APAP to be as effective as
automatic in-laboratory titrations in initiating treatment for OSA at 3-month follow-up with no significant difference in
CPAP use, ESS score, OSLER, Functional Outcomes of Sleep Questionnaire or SF-36 between the groups (Cross et al.,
2006).
In a randomized, single-blinded crossover trial Bakker et al. (2011) compared the effectiveness of CPAP and APAP (S8
Autoset II(®) , ResMed) over a period of six nights at home, separated by a four-night washout in 12 morbidly obese
OSA patients requiring high therapeutic pressure (AHI 75.8+32.7, body mass index 49.9+5.2 kg m-2 , mean pressure
16.4 cm H2O) without significant co-morbid disease. Both therapies substantially reduced the AHI (APAP 9.8+9.5 and
CPAP 7.3+6.6 events h-1; P=0.35), but residual PSG measures of disease (AHI >5) were common. APAP delivered a
significantly lower 95th percentile pressure averaged over the home-use arm than CPAP (14.2+2.7 and 16.1+1.8 cm
H2O, respectively, P=0.02). The authors concluded that this study supports the use of either APAP or manually titrated
CPAP in this specific population. Since the APAP-scored AHI significantly overestimated the level of residual disease
compared with the laboratory-scored AHI the authors recommend objective assessment by sleep study if the APAP
indicates a high level of residual disease.
McArdle et al. (2000) compared long-term outcomes in all 49 (46 accepting CPAP) patients prescribed split-night
studies with those in full-night patients, matched 1:2 using an AHI of +/-15% and Epworth score of +/-3 units. There
were no differences between the groups in long-term CPAP use, median nightly CPAP use, post-treatment Epworth
scores and frequency of nursing interventions/clinic visits required. The median time from referral to treatment was
less for the split-night patients than for full-night patients.
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Khawaja et al. (2010) reviewed 114 consecutive full-night PSGs (FN-PSG) on subjects with OSA and compared the
AHI from the first 2 hours (2 hr-AHI) and 3 hours (3 hr-AHI) of sleep with the "gold standard" AHI from FN-PSG (FNAHI), considering OSA present if FN-AHI > or = 5. The authors found that the AHI derived from the first 2 or 3 hours
of sleep is of sufficient diagnostic accuracy to rule-in OSA at an AHI threshold of 5 in patients suspected of having
OSA. This study suggests that the current recommended threshold for split-night studies (AHI > or = 20 to 40) may
be revised to a lower number, allowing for more efficient use of resources.
Collen et al. (2010) evaluated 400 consecutive patients presenting for follow-up 4-6 weeks after initiating CPAP
therapy. Among the patients, 267 and 133 underwent split- and dual-night studies, respectively. The mean number of
days between diagnosis and titration in the dual-night group was 80.5 days. There was no difference in therapeutic
adherence between groups as measured by percentage of nights used (78.7% vs 77.5%; p = 0.42), hours per night
used (3.9 vs 3.9; p = 0.95), or percentage of patients using CPAP for >4 hours per night for >70% of nights (52.9%
vs 51.8%; p = 0.81). There was no difference in use after adjusting for severity of disease. The authors concluded
that split-night PSG does not adversely affect short-term CPAP adherence in patients with OSA.
Gao et al. (2012) conducted a systematic review to evaluate the effect of automatic titration compared to manual
titration prior to CPAP treatment in OSA patients. The authors evaluated APAP in identifying an effective pressure and
the improvement of AHI and somnolence, change in sleep quality and the acceptance and compliance of CPAP
treatment compared to manual titration. Ten randomized controlled trials (849 patients) met the inclusion criteria.
Studies were pooled to yield odds ratios (OR) or mean differences (MD) with 95% confidence intervals (CI). Automatic
titration improved the AHI (MD=0.03/h, 95% CI=4.48-4.53) and ESS (SMD=0.02, 95% CI=0.34-0.31) as effectively
as manual titration. There was no difference in sleep architecture between auto titration and manual titration. There
was also no difference in acceptance of CPAP treatment or compliance with treatment. The authors concluded that
automatic titration is as effective as standard manual titration in terms of improvement in AHI, somnolence and sleep
quality, as well as acceptance and adherence to CPAP.
Actigraphy
There is very limited evidence regarding the accuracy of actigraphy for the diagnosis of circadian rhythm sleep
disorders (CRSDs). The few available studies involved different types of CRSDs and different patient populations, as
well as different actigraphy devices and reference standards, making it difficult to compare results across studies.
None of the studies evaluated the impact of actigraphy on patient management or health outcomes, and therefore the
clinical utility of this technology cannot be adequately assessed. Actigraphy was not associated with any safety issues.
Overall, the evidence to date does not establish the effectiveness of actigraphy as a stand-alone tool for diagnosis of
CRSDs (Hayes, 2010; updated 2014; archived 2015).
PAP-Nap Test
In a pilot study, Krakow et al. (2008) assessed the impact of the PAP-Nap sleep study on adherence to PAP therapy
among insomnia patients with sleep disordered breathing (SDB). The PAP-Nap test combines psychological and
physiological treatments into one procedure and includes mask and pressure desensitization, emotion-focused therapy
to overcome aversive emotional reactions, mental imagery to divert patient attention from mask or pressure
sensations and physiological exposure to PAP therapy during a 100-minute nap period. Patients treated with the PAPNap test (n=39) were compared to a historical control group (n = 60) of insomnia patients with SDB who did not
receive the test. All 99 insomnia patients were diagnosed with SDB (mean AHI 26.5 +/- 26.3, mean RDI 49.0 +/24.9), and all reported a history of psychiatric disorders or symptoms as well as resistance to PAP therapy. Among 39
patients completing the PAP-Nap, 90% completed overnight titrations, compared with 63% in the historical control
group. Eight-five percent of the nap-tested group filled PAP therapy prescriptions for home use compared with 35% of
controls. Sixty-seven percent of the nap-tested group maintained regular use of PAP therapy compared with 23% of
the control group. Using standards from the field of sleep medicine, the nap-tested group demonstrated objective
adherence of 49% to 56% compared to 12% to 17% among controls. Further results from large, prospective studies
are needed to assess the clinical value of this test.
Professional Societies
American Academy of Sleep Medicine (AASM)
In a 2005 practice parameter, AASM considers PSG the "gold standard" for the evaluation of sleep and sleep-related
breathing. However, the guidelines caution that PSG, even when accurately measured, recorded and analyzed, may
misclassify patients based upon night-to-night variability in measured parameters, the use of different types of leads
that may lead to over- or underestimation of events (e.g., use of thermistors vs. nasal cannula) and the vagaries of
the clinical definitions of disease. AASM also states that a split-night study (initial diagnostic PSG followed by CPAP
titration on the same night) is an alternative to one full night of diagnostic PSG. The split-night study may be
performed if an AHI ≥ 40/hr is documented during 2 hours of a diagnostic study but may be considered for an AHI of
20-40/hr based on clinical judgment. In patients where there is a strong suspicion of OSA, if other causes for
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symptoms have been excluded, a second diagnostic overnight PSG may be necessary to diagnose the disorder
(Kushida et al., 2005).
In December 2007, AASM released updated clinical guidelines on the use of unattended portable monitors, essentially,
at-home use, for diagnosing OSA in adults (Collop et al., 2007). In these guidelines, which consisted of a review of
the evidence, the AASM concluded:

Unattended portable monitoring for the diagnosis of OSA should be performed only in conjunction with a
comprehensive sleep evaluation.

Clinical sleep evaluations using portable monitoring must be supervised by a practitioner with board certification in
sleep medicine or an individual who fulfills the eligibility criteria for the sleep medicine certification examination.

Portable monitoring should not be used in the absence of a complete and comprehensive sleep evaluation.

Portable monitoring may be used as an alternative to standard PSG for diagnosing OSA in patients with a high
pretest probability of moderate-to-severe OSA.

Portable monitoring is not appropriate for diagnosis of OSA in patients with significant comorbidity that may
degrade the accuracy of the test (e.g., congestive heart failure). It is also not appropriate for diagnosis of OSA in
patients with coexisting sleep disorders of other types (e.g., periodic limb movement disorder).

Portable monitoring may be indicated for the diagnosis of OSA in patients for whom in-laboratory PSG is not
possible by virtue of immobility, safety, or critical illness.

Portable monitoring may be indicated to monitor the response to non-CPAP treatments for OSA.

At a minimum, the portable monitor must record airflow, respiratory effort, and blood oxygenation.

Actigraphy is not a sufficiently accurate substitute measure of sleep time to recommend its routine use.

If portable monitoring in the high-risk patient is negative or indeterminate, in-laboratory PSG is recommended.

Portable sleep monitoring is not recommended for children.
The 2009 updated AASM clinical guideline for the evaluation, management and long-term care of OSA in adults states
that MSLT is not routinely indicated in the initial evaluation and diagnosis of OSA or in an assessment of change
following treatment with nasal CPAP. However, if excessive sleepiness continues despite optimal treatment, the
patient may require an evaluation for possible narcolepsy, including MSLT (Epstein et al., 2009).
A practice parameter by Littner et al. (2005), regarding the clinical use of the MSLT and the MWT, concluded the
following:

The MSLT is indicated as part of the evaluation of patients with suspected narcolepsy to confirm the diagnosis.

The MSLT may be indicated as part of the evaluation of patients with suspected idiopathic hypersomnia to help
differentiate idiopathic hypersomnia from narcolepsy.

The MSLT is not routinely indicated in the initial evaluation and diagnosis of obstructive sleep apnea syndrome or
in assessment of change following treatment with nasal CPAP.

The MSLT is not routinely indicated for evaluation of sleepiness in medical and neurological disorders (other than
narcolepsy), insomnia or circadian rhythm disorders.

Repeat MSLT testing may be indicated in the following situations:
o When the initial test is affected by extraneous circumstances or when appropriate study conditions were not
present during initial testing
o When ambiguous or uninterpretable findings are present
o When the patient is suspected to have narcolepsy but earlier MSLT evaluation(s) did not provide polygraphic
confirmation

The MWT may be indicated in patients with excessive sleepiness to assess response to treatment.

The MWT may be used to assess an individual’s ability to remain awake when his or her inability to remain awake
constitutes a public or personal safety issue.
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Systems to record and analyze PSG information are regulated by the FDA as Class II Devices under the 510(k)
premarketing notification process. See the following website for more information (use product code GWQ):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (Accessed August 16, 2016)
The FDA has approved several home sleep testing devices as ventilatory effort recorders under the 510(k)
premarketing notification process. See the following website for more information (use product code MNR):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (Accessed August 16, 2016)
Actigraphy devices are classified as electroencephalograph devices (product code GWQ). Examples include:
 K040554: ActiGraph (Manufacturing Technology Inc.) approved on July 16, 2004.
 K011430: Actiware-PLMS Activity Recording Device (Mini Mitter Co. Inc.) approved on May 31, 2001.
 K992410: ActiTrac (Individual Monitoring Systems Inc.) approved on October 15, 1999.
 K983533: Actiwatch® (Mini Mitter Co. Inc.) approved on March 20, 1999.
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The FDA has cleared for marketing a number of different APAP devices under the 510(k) premarketing notification
process. These devices vary with respect to the physiologic variables that are monitored to determine pressure
changes and the decision paths used to determine whether and how much to increase or decrease pressure. See the
following website for more information (use product code BZD):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (Accessed August 16, 2016)
Note: CPAP and auto-CPAP devices are classified under the above product code (which also includes ventilator
devices that are not used to deliver CPAP).
CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)
Medicare covers polysomnography testing when criteria are met. Refer to the National Coverage Determinations (NCD)
for Sleep Testing for Obstructive Sleep Apnea (OSA) (240.4.1). Local Coverage Determinations (LCDs) exist, see the
LCDs for Outpatient Sleep Studies, Polysomnography, Polysomnography and Other Sleep Studies, Polysomnography
and Sleep Studies for Testing Sleep and Respiratory Disorders and Polysomnography and Sleep Testing.
(Accessed August 9, 2016)
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American Academy of Sleep Medicine (AASM). Standards for accreditation of out of center sleep testing (OCST) in
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Balk EM, Moorthy D, Obadan NO, et al. Diagnosis and treatment of obstructive sleep apnea in adults. Comparative
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POLICY HISTORY/REVISION INFORMATION
Date
04/01/2017


Action/Description
Revised coverage rationale; replaced references to “MCG™ Care Guidelines, 20th
edition, 2016” with “MCG™ Care Guidelines, 21st edition, 2017”
Archived previous policy version 2016T0334W
Attended Polysomnography for Evaluation of Sleep Disorders
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Proprietary Information of UnitedHealthcare. Copyright 2017 United HealthCare Services, Inc.